The following data is part of a premarket notification filed by Vygon Us Llc with the FDA for Vygon Nutriline And Nutriline Twinflow Catheters.
| Device ID | K052475 |
| 510k Number | K052475 |
| Device Name: | VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-09 |
| Decision Date | 2006-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002257 | K052475 | 000 |
| 30849884000840 | K052475 | 000 |
| 30849884000833 | K052475 | 000 |
| 38498840009452 | K052475 | 000 |
| 38498840009445 | K052475 | 000 |
| 38498840000138 | K052475 | 000 |